Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
Key facts
- Where
- Poznan, Szczecin, Warsaw, and Wroclaw, PolandSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 65 and 75 years old?
Source: NCT06861361, who can take part
Where in Poland
- Poznan University HospitalPoznan, PolandContact: Marek Grygier, MDNot yet recruiting
- Pomorski Uniwersytet Medyczny w SzczecinieSzczecin, PolandContact: Jaroslaw Goracy, MDNot yet recruiting
- Medical Univeristy of WarsawWarsaw, PolandContact: Janusz Kochman, MDNot yet recruiting
- Military Institute of Medicine in WarsawWarsaw, PolandContact: Piotr Kwiatkowski, MDNot yet recruiting
- National Institute of CardiologyWarsaw, PolandContact: Adam Witkowski, MDNot yet recruiting
- Military Hospital in WroclawWroclaw, PolandContact: Ściborski Krzysztof, MDNot yet recruiting
- Provincial Specialist Hospital in WroclawWroclaw, PolandContact: Marcin Protasiewicz, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ceric Sàrl
- Trial code
- NCT06861361
- Record updated
- 12 May 2026
- Original description
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.Read full original descriptionShow less
Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
Inclusion: Participant will be included if all the following criteria are met:; Patients aged ≥65 and ≤75; Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity>4m/sec); Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation.
Exclusion: Participant will not be included if any one of the following conditions exists:; Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components; Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol; Life expectancy less than 1 year; Under judicial protection, tutorship, or curatorship; Participation in another trial before the primary endpoint.